Multimodal exercise to support chemotherapy for newly diagnosed pediatric and AYA sarcoma patients
Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)
NA · University of Miami · NCT07359911
This trial will test whether a tailored exercise program helps newly diagnosed pediatric and AYA sarcoma patients start and stay on their planned chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 39 Years |
| Sex | All |
| Sponsor | University of Miami (other) |
| Drugs / interventions | Pembrolizumab, Nivolumab, Ipilumumab, Atezulimumab, Imatinib, Sunitinib, Doxorubicin, chemotherapy |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07359911 on ClinicalTrials.gov |
What this trial studies
Participants are newly diagnosed sarcoma patients aged 12–39 who are starting first-line systemic therapy and are medically cleared for activity. Enrollees will be assigned to a multimodal exercise intervention or usual care, with exit interviews to capture participant experience. The exercise program combines aerobic and resistance components tailored to each participant and is delivered during the period of chemotherapy initiation and early treatment. The primary outcome is chemotherapy uptake, measured as ability to start and continue planned systemic therapy without dose reductions or prolonged delays.
Who should consider this trial
Good fit: Ideal candidates are 12–39-year-olds with a new sarcoma diagnosis who are initiating first-line systemic therapy, can consent and speak English or Spanish, are medically cleared to exercise, and have not been regularly highly active in the prior three months.
Not a fit: Patients who are medically unable to exercise, already engage in high levels of regular exercise, are outside the 12–39 age range, or began first-line therapy more than 90 days before enrollment are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could help patients better tolerate and complete their planned chemotherapy, which may improve treatment outcomes.
How similar studies have performed: Exercise interventions have shown benefits for physical function and treatment tolerance in adult cancer populations, but comparable evidence in pediatric and AYA sarcoma patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of Sarcoma 2. Pediatric or AYA (12-39 years old) 3. Able to provide written informed consent 4. Able to speak, read, and understand English or Spanish 5. Initiating first-line systemic therapy (Doxorubicin, Ifosfamide, Gemcitabine, Docetaxel, Trabectedin, Vincristine, Irinotecan, Temozolomide, Topotecan, Etoposide, Dacarbazine, Pazopanib, Tazemetostat, Imatinib, Sunitinib, Pembrolizumab, Nivolumab, Ipilumumab, Regorafenib, Atezulimumab). Participants can be enrolled up to 90 days after starting firstline systemic therapy. 6. Approval from a medical oncology provider to participate. 7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months 8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months Exclusion Criteria: 1. \< 12 or \>39 years old 2. Unable to provide consent 3. Unable to read or understand English or Spanish 4. Oxygen-dependent 5. Unable to walk 2 blocks without assistance (excluding canes) 6. Unstable bone metastases 7. More than 90 days from initiation of first-line systemic therapy. 8. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention, as determined by the patient's provider and study clinician.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Tracy E Crane, PhD, RDN — University of Miami
- Study coordinator: Grey Freylersythe, BS
- Email: g.freylersythe@med.miami.edu
- Phone: 305-243-9832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sarcoma, Pediatric, Adolescent, Young Adult